GVP/GCP Auditor, Compliance & Quality Assurance (Japan)

Location: Japan. Remote working is supported; new hires living within a reasonably short commute of an office are encouraged to work on a hybrid basis, as agreed with the manager.

Company

hirify.global provides consulting and operational services across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Plan, prepare, and conduct GCP and GVP audits.
• Audit clinical investigator sites, clinical trial activities, vendors, CROs, and other GxP systems and processes.
• Support pharmacovigilance and safety-related audits and evaluate compliance with Japanese and international regulations.
• Prepare accurate audit reports and communicate observations and findings to clients and auditees.
• Support corrective and preventive action activities, internal audits, peer reviews, and quality reviews.
• Collaborate with global quality and compliance colleagues, subject matter experts, and clients while contributing to training and wider team initiatives.

Requirements

• Professional experience in the pharmaceutical, biotechnology, CRO, or related life-sciences industry.
• Hands-on experience supporting or conducting GCP and/or GVP audits, with recent audit experience highly desirable.
• Knowledge of Japanese regulatory requirements and the PMDA environment.
• Working knowledge of international requirements and guidance, including ICH GCP.
• Experience with audit preparation, conduct, documentation, and reporting, plus strong analytical and problem-solving skills.
• Fluent Japanese and strong professional English are required for communication with international colleagues and clients and for professional documentation.

Culture & Benefits

• Work across varied Clinical/GCP and PV/GVP audit activities in an international quality and compliance organization.
• Develop through training, peer review, practical experience, and collaboration with experienced auditors and subject matter experts.
• Build exposure to different clients, audit types, and quality systems while taking increasing ownership of audit activities in Japan.
• Work in an environment that supports independent ownership, collaboration, continuous development, diversity, equity, and inclusion.
• Remote working is supported, with hybrid office collaboration encouraged for employees located near an office.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• Applicants receive an outcome regarding their application.